University Policy, Framework Principles

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University Policy, Framework Principles
Procedures for Research Ethics

• Carlton Cooke
• Chair of Carnegie Faculty Research Ethics
  Sub-committee

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Where is the university policy, procedures and
guidance for research ethics? 2 places

• http//www.leedsmet.ac.uk/uso/aqs/docs/Published-P
  olicy-Framework-res20Ethics.doc
• http//www.leedsmet.ac.uk/research/PublishedPolicy
  Framework(res_Ethics).doc

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Types of ethical review?

• Depends on nature of research
• Authorisation or Approval
• Valuable part of the research process for all
  researchers

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Guiding Principles for you and committees

• Beneficence do positive good
• Non-maleficence do no harm
• Informed consent
• Confidentiality / Anonymity

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ETHICAL FRAMEWORK IN PRACTICE

• Definitions
• Research a form of disciplined enquiry which
  aims to contribute to a body of knowledge or
  theory.
• Research Ethics are the moral principles guiding
  the planning and conduct of research, the
  publication of outcomes, and post-project care
  and/or disposal of records or materials.

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Excluded Matters those not involving human
participants or subjects

• i.e. not considered to involve either human
  participants or human subjects routine audit,
  performance reviews, quality assurance studies,
  polling on current public policy issues literary
  or artistic criticism. Service evaluations are
  normally excluded matters, but this may not be
  the case in NHS-related matters.
• Material in the public domain is not considered
  to apply to human subjects, for example
  published biographies, newspaper accounts,
  published minutes, books or articles. Interviews,
  diaries or letters in the public domain.
• Research projects which are predominantly
  undertaken using material in the public domain
  will not require ethical approval. There are some
  exceptions when the use of secondary data sets
  will require ethical approval.

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Definitions continued

• Human Participants are
• living human beings, including embryos and
  foetuses, human tissue and body parts
• human beings who have recently died, including
  cadavers, human remains and body parts
• collective organisations for example companies,
  corporations, community groups.
• Human Subjects are the subject(s) of data and
  records which have been collected and stored as a
  record at individual level - for example medical,
  genetic, financial, personnel, criminal and
  administrative records and test results
  including scholastic achievements.

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Research Proposals from postgraduate students

• Authorisation - Excluded Matters
• Where the proposed project falls within the
  category of excluded matters, it should be
  referred to the local Research Ethics
  Co-ordinator for the process of authorisation.
• Do you know who they are in your area/faculty?
• Have you talked to them about your research?

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Research Proposals from postgraduate students

• Local Level Approval
• Where the proposed project is one which can be
  approved at local level, such approval should be
  sought from the local Research Ethics
  Co-ordinator.

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Research Proposals from postgraduate students

• Faculty Level Approval
• Where the proposed project is one which cannot be
  approved at local level, the project must be
  forwarded to the faculty research ethics
  sub-committee for consideration.

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Research Proposals from postgraduate students

• Prior Approval
• No engagement with human participants, or human
  subjects, or other forms of data collection
  requiring ethical approval, can commence before
  approval is received.

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Ethical Issues for consideration in the
preparation of proposals

• Risk
• Identify both the nature of any potential risks
  of the proposed project and how such risks will
  be managed and minimised through the research
  strategy and protocols used.

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Ethical Issues for consideration in the
preparation of proposals

• Occluded Research
• These are projects where full information to the
  participant would invalidate the research (e.g.
  psychological experiments where prior disclosure
  would invalidate the responses and so contradict
  the purpose of the project).

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Ethical Issues for consideration in the
preparation of proposals

• Covert Research
• Covert projects might be found in fields of
  deviance studies, and may include investigation
  of illegal behaviour (where the written consent
  of the participant would create risk for him or
  her) or where such investigation might itself be
  covert.

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Ethical Issues for consideration in the
preparation of proposals

• Selection of Participants/Subjects
• On what basis will this be done, and how will the
  researchers assure the university that this
  participation is voluntary? Is it intended that
  payments will be made, and if so, details and
  rationale will be required.
• Information to the Participant or Subject of
  Research
• How will the participant be given full
  information on the aims, methods, sources of
  funding of the project, and proposed use of the
  study? Will the anticipated benefits and
  potential risks of the study, and any discomfort
  it may entail be included? Is the right to
  withdraw from the project fully set out?
• A draft Information Sheet must be included in the
  application.

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Ethical Issues for consideration in the
preparation of proposals

• Consent
• How will Informed Consent be obtained? If consent
  will not be in written form, the justification
  for this should be included, and full details of
  how consent will be provided.
• A draft Consent Form must be included in the
  application which makes it clear that consent is
  Informed Consent.
• Children, Vulnerable Adults
• If the study involves people in these groups what
  specific provisions will be put in place, and how
  will Informed Consent be obtained and from whom?
  A draft Consent Form must be included in the
  application.
• If relevant, have all researchers on the project
  received Criminal Records Bureau clearance?

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Authorisation or local-level approval

• This is undertaken within the School/Academic
  Unit.
• Authorisation
• This process always takes place at local level.
  Authorisation for research is required by
  postgraduate students as a means of confirming
  that the research to be undertaken is an excluded
  matter and therefore does not need ethical
  approval.
• Local Level Approval
• Depending on the nature of the project, local
  level approval may also be given to postgraduate
  proposals.

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Local level approval

• Approvable
• Low-risk projects, which include the following
• projects in which the ethical issues are not
  complex or sensitive
• projects where there is minimal risk of harm
  either to participants or researcher
• (for postgraduate proposals) where adequate
  supervision of the project is demonstrable.
• Not approvable at local level
• projects which do not comply with the provisions
  above
• all requests of approval of projects involving
  children or vulnerable persons will normally be
  referred to the faculty
• all requests for approval of Occluded or Covert
  research projects.

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Faculty approval

• Approval should be sought from the faculty where
  there are substantial or complex ethical issues
  involved or where this is a requirement for
  funding by an external body for example the
  Economic and Social Research Council.
• Where the research comes under the jurisdiction
  of a Local Medical Research Ethics Committee, or
  equivalent, a copy of the documentation from that
  body must be included with the application.
  Faculty approval will be based on the NHS
  approval (no need for duplicated assessment).
  This does not preclude the faculty additionally
  requiring compliance with any university
  requirement.

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Local Research Ethics Co-ordinators

• Find out who they are in your faculty/school/area
  of research and talk to them if you have not done
  so already and do this well in advance of when
  you want to start your research.

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Practical guidance

• Allow sufficient time to submit for a scheduled
  meeting and re-submit for next meeting or chairs
  action (i.e. well before research is due to start
  )
• Give clear explanations to questions in boxes
• If the box tells you to answer in a certain way
  do so
• If the question is not applicable to your
  research just say so
• Proof read and spell check your submission and
  supporting material
• Get your director of studies to check and okay
  your submission before you submit it to the
  committee
• Make sure information sheet and consent form are
  included and have been checked as fit for purpose
  (i.e. correct language, all the necessary
  information)
• Use the examples of good practice submission on
  portal as a guide
• Read and use guidance for ethics in your area of
  research

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The Portal

• Go into portal from university home page (login
  user name password)
• Click on groups on top of your portal home page
• Examples are in Leeds Met Research group (you
  will need to join first time you go in)
• Then click on sub groups on left
• Then click on Carnegie PG Research
• Then click on files on the left and then select
  ethics good practice eg
• Only look at information and consent forms as
  examples as the submissions are on old forms!
• File with links to Ethics codes of practice also
  there